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FDA Devices Verify with FDA Devices → Moderate Class II Ongoing

Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ; 6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ; 7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ; 8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ; 9) VAGINAL HYSTERECTOMY CDS, Pack Num

Reported: September 18, 2024 Initiated: April 8, 2024 #Z-3049-2024

MEDLINE INDUSTRIES, LP - Northfield issued this FDA Devices recall on September 18, 2024. Classified as Moderate severity (Class II). The recall was issued because: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, bre…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-3049-2024) was formally reported on September 18, 2024, with the manufacturer initiating the action on April 8, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. MEDLINE INDUSTRIES, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.

The documented reason for this recall is: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. Distribution data in the federal record shows the product reached: Worldwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

Unknown

Related Recalls

6

6 from same agency

Product Description

Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ; 6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ; 7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ; 8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ; 9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ; 10) LAVH CDS, Pack Number CDS920130K ; 11) LAVH PROCEDURE, Pack Number CDS980754R ; 12) LAVH PROCEDURE, Pack Number CDS980754S ; 13) VAG HYST KIT, Pack Number CDS981313L ; 14) VAG HYST KIT, Pack Number CDS981313M ; 15) MINOR LITHOTOMY , Pack Number CDS982037W ; 16) MAJOR LITHOTOMY , Pack Number CDS982052V ; 17) D&C CDS , Pack Number CDS982061K ; 18) LAVH, Pack Number CDS982273Q ; 19) LAVH, Pack Number CDS982273R ; 20) LAVH, Pack Number CDS982273S ; 21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ; 22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ; 23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ; 24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ; 25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ; 26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ; 27) VAGINAL MAJOR , Pack Number CDS982689S ; 28) VAGINAL MAJOR , Pack Number CDS982689T ; 29) GYN/ABDOMINAL , Pack Number CDS982725K ; 30) GYN/ABDOMINAL , Pack Number CDS982725N ; 31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ; 32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ; 33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ; 34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ; 35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ; 36) CUH LITHOTOMY CDS , Pack Number CDS983207M ; 37) CUH LITHOTOMY CDS , Pack Number CDS983207N ; 38) VAGINAL MINOR , Pack Number CDS983268I ; 39) LAVH CDS, Pack Number CDS983411I ; 40) LAVH CDS, Pack Number CDS983411J ; 41) LAVH CDS, Pack Number CDS983411K ; 42) LAVH PROCEDURE, Pack Number CDS983449L ; 43) LAVH PROCEDURE, Pack Number CDS983449M ; 44) LAVH PROCEDURE, Pack Number CDS983449N ; 45) LAVH CDS, Pack Number CDS983455C ; 46) MAJOR VAGINAL , Pack Number CDS983497J ; 47) MAJOR VAGINAL , Pack Number CDS983497L ; 48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ; 49) VAG HYST CDS, Pack Number CDS983697J ; 50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ; 51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ; 52) GYN MINOR CDS , Pack Number CDS983985G ; 53) GYN ABDOMINAL CDS , Pack Number CDS983988A ; 54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ; 55) TVT CDS , Pack Number CDS984091J ; 56) GROTH VAGINAL CDS , Pack Number CDS984201T ; 57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ; 58) GYN CDS , Pack Number CDS984676C ; 59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304; 60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ; 61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ; 62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ; 63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ; 64) MAJOR LITHOTOMY , Pack Number CDS985547N ; 65) PROCEDURE TRAY, Pack Number DYNDA2966; 66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ; 67) TVH TRAY, Pack Number DYNJ00460L ; 68) TVH TRAY, Pack Number DYNJ00460M ; 69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ; 70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ; 71) LAVH PACK-LF, Pack Number DYNJ00470K ; 72) LAVH PACK-LF, Pack Number DYNJ00470L ; 73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ; 74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ; 75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ; 76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ; 77) LAVH PACK-LF, Pack Number DYNJ0372824Q ; 78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ; 79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ; 80) VAGINAL HYSTERECTOMY PACK-

Reason for Recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Details

Distribution
Worldwide distribution.
Location
Northfield, IL

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-3049-2024
Date reported September 18, 2024
Date initiated April 8, 2024
Recalling firm MEDLINE INDUSTRIES, LP - Northfield
Units affected Not disclosed
Distribution Worldwide distribution.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Frequently Asked Questions

What product was recalled? ▼
Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ; 6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ; 7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ; 8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ; 9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ; 10) LAVH CDS, Pack Number CDS920130K ; 11) LAVH PROCEDURE, Pack Number CDS980754R ; 12) LAVH PROCEDURE, Pack Number CDS980754S ; 13) VAG HYST KIT, Pack Number CDS981313L ; 14) VAG HYST KIT, Pack Number CDS981313M ; 15) MINOR LITHOTOMY , Pack Number CDS982037W ; 16) MAJOR LITHOTOMY , Pack Number CDS982052V ; 17) D&C CDS , Pack Number CDS982061K ; 18) LAVH, Pack Number CDS982273Q ; 19) LAVH, Pack Number CDS982273R ; 20) LAVH, Pack Number CDS982273S ; 21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ; 22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ; 23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ; 24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ; 25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ; 26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ; 27) VAGINAL MAJOR , Pack Number CDS982689S ; 28) VAGINAL MAJOR , Pack Number CDS982689T ; 29) GYN/ABDOMINAL , Pack Number CDS982725K ; 30) GYN/ABDOMINAL , Pack Number CDS982725N ; 31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ; 32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ; 33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ; 34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ; 35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ; 36) CUH LITHOTOMY CDS , Pack Number CDS983207M ; 37) CUH LITHOTOMY CDS , Pack Number CDS983207N ; 38) VAGINAL MINOR , Pack Number CDS983268I ; 39) LAVH CDS, Pack Number CDS983411I ; 40) LAVH CDS, Pack Number CDS983411J ; 41) LAVH CDS, Pack Number CDS983411K ; 42) LAVH PROCEDURE, Pack Number CDS983449L ; 43) LAVH PROCEDURE, Pack Number CDS983449M ; 44) LAVH PROCEDURE, Pack Number CDS983449N ; 45) LAVH CDS, Pack Number CDS983455C ; 46) MAJOR VAGINAL , Pack Number CDS983497J ; 47) MAJOR VAGINAL , Pack Number CDS983497L ; 48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ; 49) VAG HYST CDS, Pack Number CDS983697J ; 50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ; 51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ; 52) GYN MINOR CDS , Pack Number CDS983985G ; 53) GYN ABDOMINAL CDS , Pack Number CDS983988A ; 54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ; 55) TVT CDS , Pack Number CDS984091J ; 56) GROTH VAGINAL CDS , Pack Number CDS984201T ; 57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ; 58) GYN CDS , Pack Number CDS984676C ; 59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304; 60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ; 61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ; 62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ; 63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ; 64) MAJOR LITHOTOMY , Pack Number CDS985547N ; 65) PROCEDURE TRAY, Pack Number DYNDA2966; 66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ; 67) TVH TRAY, Pack Number DYNJ00460L ; 68) TVH TRAY, Pack Number DYNJ00460M ; 69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ; 70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ; 71) LAVH PACK-LF, Pack Number DYNJ00470K ; 72) LAVH PACK-LF, Pack Number DYNJ00470L ; 73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ; 74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ; 75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ; 76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ; 77) LAVH PACK-LF, Pack Number DYNJ0372824Q ; 78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ; 79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ; 80) VAGINAL HYSTERECTOMY PACK-. Recalled by MEDLINE INDUSTRIES, LP - Northfield.
Why was this product recalled? ▼
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-3049-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3049-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).